Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

The Flexible Ureterorenoscope is a single-use endoscope inserted through the urethra to visualize the urinary tract (urethra, bladder, ureter, calyces, and renal papillae). It works with a Video Processor to provide visualization and can be used with accessories to perform diagnostic and therapeutic urological procedures.

The subject device differs from the predicate in distal end diameter, field of view, and patient-contacting materials. Key similarities include the same fundamental technology, insertion section length, deflection direction, depth of field, number of uses, and sterilization method. The main technical difference is that the subject device has LED illumination generated from the handle and transmitted via optical fibers to the distal tip, whereas the predicate has LEDs in the distal tip itself.

Electrical safety and EMC per ANSI AAMI IEC60601-1:2:2005/2012 and ANSI AAMI C1:2009. Photobiological safety per IEC 62471:2006. Mechanical and optical performance per ISO 8600. Biocompatibility per ISO 10993-1 and FDA Guidance. Sterilization per ISO 11135:2014. Shelf life per ASTM F1980-21. Package validation per ISO 11607-1:2019 and ASTM D4169-22.

The device is substantially equivalent because both the subject and predicate devices share the same fundamental technology, intended use, and regulatory classification for visualizing the urinary tract with flexible endoscopes. The differences in distal end diameter, field of view, and illumination method (handle-based with fiber transmission vs. distal LEDs) do not raise new safety or effectiveness questions, as both designs have been tested to equivalent performance standards. Comprehensive nonclinical testing demonstrates the subject device performs as safely and effectively as the predicate.